''Keepsake'' ultrasounds -- those adorable fuzzy pre-baby pictures -- have pitted eager consumers against industry guidelines and federal finger-wagging over the ''off-label'' use of a medical device for ''entertainment'' purposes.

Critics immediately panned Cruise for exposing the baby to ''unnecessary risk.'' Worse, he let the world in on a dirty little secret: Anyone -- at least anyone plunking down some serious money -- can buy an ultrasound machine.

Incensed California legislators took action. A bill restricting sale of the machines to licensed medical professionals overwhelmingly passed the Assembly there in May and is now in the Senate.

In the right hands -- likely not Tom Cruise's -- ultrasound technology is perfectly safe, many medical experts believe. But when it comes to ''keepsake'' ultrasounds, in most states, including Florida, there's a gaping hole between local and federal oversight that some worry could leave consumers at risk.

Typically, doctors do ''diagnostic'' ultrasound exams at about 20 weeks to check for growth, general anatomy, placental location and for some birth defects.

Since the late 1990s, when cheap, fast computer power helped put 3-D and 4-D technology and its awesome images into many clinics, parents have begged for more pictures.

Ultrasound, which uses sound waves instead of radiation, has to be one of the safest scanning technologies around. Used for more than 30 years, there's no evidence it has ever harmed a fetus when used properly.

Still, most doctors have been reluctant to schedule nonmedical ultrasound sessions, although many will give patients a keepsake snapshot from a diagnostic exam.

The clearest keepsake pictures, though, are taken later in pregnancy, prompting patients to search for places that will do sonograms strictly for fun.

Catherine Russell, clinic spokeswoman, said nonmedical ultrasounds, like cosmetic surgery or Botox injections, are not ''medically indicated,'' but something patients want.

The Food and Drug Administration considers ''keepsake'' fetal videos an ''unapproved use of a medical device,'' and says using one without a physician's order may violate state or local laws.

But medical professional groups had problems with charging patients for nonmedical services, and others raised concerns about false alarms or problems being missed by untrained operators, he says.

He notes that the FDA says that while ultrasound fetal scanning is ''generally considered safe,'' it ''cannot be regarded as completely innocuous'' because it can produce vibrations and rise in temperature of tissues. While there is no evidence these physical effects harm a fetus, the FDA says, ''casual exposure'' ought to be avoided.

Shields, at the University of Washington, says the machine wasn't designed to make ''pretty baby pictures.'' High settings can cause ''thermal heating of tissue,'' he says. ''If it's high enough, you literally fry the tissue.'' So it's ''incredibly important'' that the operator understand the underlying physics, he says.

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